A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age With Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 84
- 主要终点
- Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders
研究概览
简要总结
The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).
详细描述
Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females weighing ≥10 kg and ≥2 and <18 years old at the time of consent for screening.
- •Have moderate to severe UC.
- •Have failed corticosteroids, biologics, (for example, anti-tumor necrosis factor (TNF) antibodies or anti-integrin antibodies), immunomodulators (for example, azathioprine, thiopurines or methotrexate) or Janus Kinase (JAK)-Inhibitor treatment.
- •Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report.
排除标准
- •Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis.
- •Have immune deficiency syndrome.
- •Previous bowel resection or intestinal surgery.
- •Evidence of toxic megacolon.
- •History or current evidence of cancer of the gastrointestinal tract.
研究组 & 干预措施
Mirikizumab Weight-Based Group 2
Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.
干预措施: Mirikizumab SC (Drug)
Mirikizumab Weight-Based Group 1
Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).
干预措施: Mirikizumab IV (Drug)
Mirikizumab Weight-Based Group 1
Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).
干预措施: Mirikizumab SC (Drug)
Mirikizumab Weight-Based Group 2
Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.
干预措施: Mirikizumab IV (Drug)
Mirikizumab Weight-Based Group 3
Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.
干预措施: Mirikizumab IV (Drug)
Mirikizumab Weight-Based Group 3
Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.
干预措施: Mirikizumab SC (Drug)
结局指标
主要结局
Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders
时间窗: Baseline to Week 52
次要结局
- Percentage of Participants in MMS Clinical Remission(Week 12)
- Percentage of Participants in MMS Clinical Response(Week 12)
- Percentage of Participants with Endoscopic Remission(Week 12)
- Percentage of Participants with Endoscopic Improvement(Week 12)
- Percentage of Participants Achieving Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response(Week 12)
- Percentage of Participants Achieving PUCAI Clinical Remission(Week 52)
- Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement(Week 52)
- Percentage of Participants Achieving MMS Clinical Response(Week 52)
- Percentage of Participants Achieving MMS Clinical Remission(Week 52)
- Percentage of Participants Achieving PUCAI Clinical Response(Week 52)
- Percentage of Participants Achieving Endoscopic Remission(Week 52)
- Percentage of Participants Achieving Endoscopic Improvement(Week 52)
- Percentage of Participants Achieving MMS Clinical Remission without Surgery at Week 52 among Clinical Responders at Week 12 and without the Use of Corticosteroids(Baseline to Week 52)
- Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab(Baseline to Week 52)
- PK: Cmax of Mirikizumab(Baseline to Week 52)
- Percentage of Participants Achieving PUCAI Clinical Remission(Week 12)
- Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement(Week 12)